Post-MI PET Scan Imaging of Inflammation
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02281305 |
|
Recruitment Status : Unknown
Verified October 2014 by Spyridon Deftereos, G.Gennimatas General Hospital.
Recruitment status was: Recruiting
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
|
Sponsor:
G.Gennimatas General Hospital
Collaborator:
Academy of Athens
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myocardial Infarction | Drug: Colchicine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine |
| Study Start Date : | October 2014 |
| Estimated Primary Completion Date : | April 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Colchicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Colchicine Active treatment group
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
|
Drug: Colchicine |
|
Placebo Comparator: Control group
Drug: Placebo
|
Primary Outcome Measures :
- Degree of inflammation of the involved myocardium as assessed by the PET scan [ Time Frame: 5 days post-MI ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The study will enroll patients 18 years old or older
- Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation > 1 mm in two contiguous limb leads or ST segment elevation > 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.
Exclusion Criteria:
-
Excluded patients:
- with age > 80 years old
- with active inflammatory diseases, infectious diseases or known malignancy
- under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- with known hypersensitivity-allergy to colchicine
- under chronic treatment with colchicine
- with severe renal failure (eGFR < 30 ml/min/1.73 m2)
- with hepatic failure (Child - Pugh class B or C)
- presented with cardiac arrest
- presented with ventricular fibrillation
- presented with cardiogenic shock
- with stent thrombosis
- with angina within 48 hours before infarction
- with previous myocardial infarction in the affected territory
- with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281305
Contacts
| Contact: Spyridon Deftereos, MD | +302107768560 | spdeftereos@gmail.com | |
| Contact: Georgios Giannopoulos, MD | +302107768560 | ggiann@med.uoa.gr |
Locations
| Greece | |
| Athens General Hospital "G. Gennimatas" | Recruiting |
| Athens, Attika, Greece, 11527 | |
| Contact: spyridon Deftereos, MD +302107768560 spdeftereos@gmail.com | |
Sponsors and Collaborators
G.Gennimatas General Hospital
Academy of Athens
Investigators
| Principal Investigator: | Constantinos Anagnostopoulos, MD | Biomedical Research Foundation of Academy of Athens | |
| Principal Investigator: | Christos Angelidis, MD | Athens General Hospital "G. Gennimatas" |
| Responsible Party: | Spyridon Deftereos, Director, Cardiac Catheterization Department, G.Gennimatas General Hospital |
| ClinicalTrials.gov Identifier: | NCT02281305 History of Changes |
| Other Study ID Numbers: |
22977 / 29-08-2014 |
| First Posted: | November 3, 2014 Key Record Dates |
| Last Update Posted: | November 3, 2014 |
| Last Verified: | October 2014 |
Additional relevant MeSH terms:
|
Inflammation Infarction Myocardial Infarction Pathologic Processes Ischemia Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |